Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity: A Pragmatic Trial of an Outpatient-based Virtual Transitional Care Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Any hospital readmission for any cause within 6 months
研究概览
简要总结
Stroke is the leading cause of death and adult disability in Canada. Sixty percent of these older adults (> 65 years) will return to their homes after a stroke and will require ongoing rehabilitation. About 92% of older adults have two or more chronic conditions. These patients often require services from a number of providers in a number of settings and are therefore, susceptible to fragmented health care when transitioning from hospital to home. New interventions are needed to improve the quality of care as patients move from hospital to home after a stroke. The proposed research project will examine the impact of a new intervention on patient/caregiver health, patient/caregiver and provider experience and costs, compared to usual health care services. The new intervention will be coordinated by a system navigator and consists of four core components: 1) development of a comprehensive discharge plan, 2) up to 6 home visits (supported by phone calls) by an interprofessional outpatient team, 3) monthly case conferences including the interprofessional care team who will discuss and focus on the patient's goals and care needs, and 4) linkages to other healthcare and community services. This multidisciplinary project will build on our previous study, which provided the groundwork for further study of this new intervention.
详细描述
The overall purpose of this pragmatic randomized controlled trial (RCT) is to adapt, implement and evaluate a novel person- and family-centred Transitional Care Stroke Intervention (TCSI) for older adults (> 55 years) with stroke and multimorbidity (>2 chronic conditions) and their caregivers. The TCSI is a theory- and evidence-based 6-month intervention designed to improve the health, experience, and quality of transitioning from hospital-to-home for this vulnerable population. An effectiveness-implementation hybrid type I design will be used, which will focus primarily on examining the effectiveness of the TCSI on quadruple aim outcomes: (i) patient and caregiver health outcomes, (ii) patient and caregiver experience, (iii) provider/manager experience, and (iv) patient healthcare service use costs, and will also evaluate implementation outcomes (e.g., barriers, facilitators, fidelity). Our earlier pre-post study provided evidence to support the feasibility, acceptability and preliminary effectiveness of the TCSI on reducing hospital readmissions and emergency department visits (for any cause). These improvements were achieved at no additional cost. The key components of the TCSI in this earlier study included home visits supported by telephone calls by an interprofessional team (IP), patient-centered care planning, and care coordination/recruitment. The following enhancements to the TCSI will be included in the trial: 1) integrating the navigator role across the care continuum, 2) testing the TCSI with a larger sample and more rigorous (RCT) design, 3) enhancing patient self-management, and 4) evaluating the impact of the intervention on caregiver health outcomes and experience. These improvements alongside the inclusion of additional evaluation measures will enable rigorous evaluation of the TCSI and position it for future scale-up and spread
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Study patients will be blinded to their group allocation. Those aware that they are receiving or not receiving the intervention are more likely to provide biased assessments of the effectiveness of the intervention than blinded participants. Participants who are aware that they are not receiving the intervention may be less likely to comply with the trial protocol, and more likely to drop out of the trial. To minimize assessment bias, Research Assistants will be blinded to group allocation. The statistical analyst will be blinded to the group allocation of the participants when analyzing the data.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 55 years or greater
- •hospitalized for stroke and receiving in-patient rehabilitation
- •diagnosed with at least 2 or more chronic conditions
- •will be discharged to the community from in-patient rehabilitation (not hospital or long-term care)
- •not planning to move out of the study catchment area in the next 6 months
- •referred to outpatient stroke rehabilitation services
- •capable of providing informed consent, or have a substitute decision-maker who is capable and able to provide informed consent on his/her behalf
- •competent in English, or has an interpreter who is competent in English
排除标准
- •less than 55 years of age
- •fewer than two chronic conditions
- •planned discharge to hospital or long-term care facility
- •cognitively impaired with no substitute decision maker who is capable to provide consent
- •not competent in English with no interpreter
结局指标
主要结局
Any hospital readmission for any cause within 6 months
时间窗: 6-months
The Health and Social Services Utilization Inventory (HSSUI) will be used to identify patients with any readmission to hospital for any cause within 6 months from study enrolment. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The question in the HSSUI pertaining to any hospital readmission for any cause will be: "Have you been readmitted to the hospital in the past 6-months?" (Yes / No).
次要结局
- Change in self-efficacy(Baseline; 6 months)
- Change in depressive symptoms(Baseline; 6 months)
- Change in community integration(Baseline; 6 months)
- Change in health-related quality of life - mental health(Baseline; 6 months)
- Change in use of health and social services(Baseline; 6 months)
- Change in health-related quality of life - physical health(Baseline; 6 months)
- Change in anxiety(Baseline; 6 months)
- Change in stroke physical function(Baseline; 6 months)
- Time to any hospital readmission for any cause within 6 months(Baseline; 6 months)
- Change in caregiver strain(Baseline; 6 months)
- Relative risk of any hospital readmission for any cause within 6 months(Baseline; 6 months)